Packaging mix-up of birth control pills could lead to unintended pregnancies

Lupin Pharmaceuticals Inc. have made a horrendous error with their packaging which could mess up birth control plans for many women.

On 30^th May 2017, Lupin Pharmaceuticals Inc. announced a recall for one lot of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1mg/0.02mg chewable and ferrous fumarate 75mg) tablets after a customer complained there had been a mix-up with the packaging, missing expiry dates and incorrect lot information.

There’s a concern that the mix-up could result in women taking chemically inactive pills on days when they should be taking active tablets, and therefore risk unintended pregnancy.

Birth control pill issues…

The customer complained about the packaging error in which the “blister” plastic covering was erroneously rotated 180 degrees. This had the effect of reversing the weekly schedule, which means that the first 4 days of taking the pill would have reportedly had four non-hormonal placebo tablets instead of the active tablets.

The pills that are being recalled are packed in blister packs containing 28 tablets. The 24 white tablets are active tablets marked with “LU” on one side and “N81” on the other. There are four tablets that contain chemically inactive pills marked with “LU” on one side and “M22” on the other side.

The recall states:

“…as a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy.”

Lupin seems to have realised the disastrous consequences many users could face as a result of their error. For obvious reasons, this is a potentially serious problem for some people.

For those who are unaware with how oral contraceptives work, some are usually taken in a certain order that mirrors a standard period. This means the dose shouldn’t be given several days each month. To assist with the routine, manufacturers usually place pills that have no chemical effect in designated days so there aren’t any disruptions. Vice explains that, “the four darker placebo tablets [are] at the beginning of the 28-day cycle, instead of at the end after the 24 white pills.”

Large scale recall

It’s thought the pills were distributed to wholesalers, clinical establishments and retail pharmacies alike. Users who take affected birth control pills should notify their doctor/pharmacy and return the product from where it was purchased.

Regulators noted that either new or previous users of the pill may not be aware of the reversed order, which of course may increase the likelihood of the pills being taken out of sequence.

Risks

For users where pregnancy could cause harm, an unintended pregnancy may cause serious adverse health effects to the mother and foetus. This could include death. As of 25^th May, there hasn’t been any reports of such incidents, but this risk is ongoing for a number individuals.

Another risk associated with improperly oriented packaging can include birth defects.